A ready-to-use urinary catheter assembly

0001This invention relates to at least one urinary catheter assembly comprising a urinary catheter having on at least a part of its surface a hydrophilic surface layer intended to produce a low-friction surface character of the catheter by treatment with a liquid swelling medium prior to use of the catheter and a catheter package having a cavity for accommodation of the catheter.

0002Urinary catheters of the kind to which the invention pertains are known, inter alia, from <patcit id="pcit0001" dnum="EP0217771A"><text>EP-A-0 217 771</text></patcit>, <patcit id="pcit0002" dnum="EP0586324A"><text>EP-A-0 586 324</text></patcit> and <patcit id="pcit0003" dnum="WO9416747A"><text>WO 94/16747</text></patcit>, whereas various forms of catheter packages are known from <patcit id="pcit0004" dnum="US3035691A"><text>US-A-3,035,691</text></patcit>, <patcit id="pcit0005" dnum="US3648704A"><text>US-A-3,648,704</text></patcit>, <patcit id="pcit0006" dnum="US3967728A"><text>US-A-3,967,728</text></patcit>, <patcit id="pcit0007" dnum="US4204527A"><text>US-A-4,204,527</text></patcit>, <patcit id="pcit0008" dnum="US4269310A"><text>US-A-4,269,310</text></patcit>, <patcit id="pcit0009" dnum="US4379506A"><text>US-A-4,379,506</text></patcit>, <patcit id="pcit0010" dnum="US5454798A"><text>US-A-5,454,798</text></patcit>, <patcit id="pcit0011" dnum="GB2284764A"><text>GB-A-2,284,764</text></patcit>, <patcit id="pcit0012" dnum="DE2317839A"><text>DE-A-2,317839</text></patcit>, <patcit id="pcit0013" dnum="EP0677299A"><text>EP-A-0 677 299</text></patcit> and DK Design Registration No. 0932 1986.

0003<patcit id="pcit0014" dnum="US3648704A"><text>US-A-3,648,704</text></patcit>, <patcit id="pcit0015" dnum="US3967728A"><text>US-A-3,967,728</text></patcit>, <patcit id="pcit0016" dnum="US4269310A"><text>US-A-4,269,310</text></patcit>, <patcit id="pcit0017" dnum="GB2284764A"><text>GB-A-2,284,764</text></patcit> and <patcit id="pcit0018" dnum="EP0677299A"><text>EP-A-0 677 299</text></patcit> disclose a conventional urinary catheter assembly comprising a catheter of the kind where prior to insertion of the catheter into the urethra the tip of the catheter is to be lubricated with a gel-like lubricant and a package where such a lubricant is accommodated in a rupturable pouch connected with or located within the package itself adjacent to the tip of the catheter or supplied together with the catheter package for connection therewith prior to use of the catheter.

0004An important feature of any urinary catheter used for intermittent catherisation of the bladder of an incontinent user is the ability of the catheter to slide easily through the urethra without exposing the urethral walls to any risk of damage. Catheters of the kind to which the inventions pertains have been developed to meet this need by imparting an extremely low friction character to at least the part of the surface of the catheter which is actually introduced into the urethra. The low friction surface character is obtained by incorporating into the relevant part of the catheter at least a hydrophilic surface layer, typically in the form of a coating, and exposing this layer or coating to contact with a liquid swelling medium immediately prior to use.

0005In order to maintain the low friction surface character during location of the catheter in the urethra and subsequent with drawal therefrom and hereby reduce stinging pain it is further known to incorporate an osmolality promoting agent, such as NaCl, in the hydrophilic coating.

0006When catheters of this kind are used directly by end users outside the medical environment of a hospital or a clinic, e.g. by or tetraplegic patients who often have a very poor dexterity, and therefore need a very simple insertion procedure, the most common liquid swelling medium used for preparation of the catheter immediately prior to use would be normal tap water.

0007In order to reduce the risc of infection inherent with the performance of intermittent catherisation of the bladder both the actual swelling medium used and the environment in which the catherisation is performed need, however, to be as clean and antiseptic as possible. Evidently, this need may be very difficult to meet in many daily life situations, as where catherisation must be performed outside the users normal daily environment, e.g. in public toilets, where neither the water supply nor the general state of cleanliness can be expected to be of a sufficiently high standard. Moreover, many disabled users have severe difficulties in entering available toilet rooms due to simple physical barriers like narrow access ways, stairs and the like.

0008On this background, it is the object of the invention to improve and facilitate the performance of intermittent urinary catherisation in any type of environment by providing a ready to use urinary catheter assembly comprising a catheter which can be withdrawn from its package and is prepared for direct insertion in the urethra and in a substantially sterile condition, whereby the general quality of life for users of intermittent catherisation would be greatly improved.

0009In order to meet this and other objects of the invention, as set forth in the following, a urinary catheter according to the invention is a catheter according to claim 1.

0010The term "gas impermeable" material should be understood in this context to mean any material that will be sufficiently tight against diffusion by evaporation of the actual liquid swelling medium for a period exceeding the recommended shelf life time of the catheter assembly which could be up to five years, typically 36 months.

0011The compartment for the swelling medium is separated from the cavity for accommodation of the catheter, and the swelling medium is confined in said compartment in a liquid state until the intended use of the catheter.

0012In one embodiment of this type, the compartment for the swelling medium may be formed by a container arranged around a proximal part of said catheter not provided with said hydrophilic layer, said catheter passing through said container via sealed openings, said catheter and said container being arranged in said package to allow said catheter to be drawn through said container by withdrawal of the catheter from the package.

0013In order to reduce the amount of liquid swelling medium required for activation of the hydrophilic surface coating of the catheter, the latter may advantageously be provided with means preventing said swelling medium from getting into contact with internal or external surface parts of the catheter not provided with said hydrophilic layer for an activation period during which said medium is applied to the surface part provided with said hydrophilic layer.

0014In the following, the invention will be explained in more detail by means of various embodiments illustrated in the accompanying drawings, in which <ul id="ul0001" list-style="none" compact="compact"><li><figref idref="f0002">figures 1 and 2</figref> are upper plan views of a first and second embodiment, respectively;</li><li><figref idref="f0003">figures 3 and 4</figref> are side views of a third and a fourth embodiment, respectively;</li><li><figref idref="f0002">figure 5</figref> is a side view of a fifth embodiment;</li><li><figref idref="f0004">figure 6</figref> is a plan view of an sixth embodiment;</li><li><figref idref="f0001">figure 7</figref> illustrates introduction of a prepared catheter;</li><li><figref idref="f0003">figure 8</figref> illustrates a part of a catheter provided with means to reduce the amount of liquid swelling required for activation of a hydrophilic surface coating; and</li><li><figref idref="f0005 f0006 f0007 f0008 f0009 f0010 f0011">figures 9 to 23</figref> are representations of a number of further embodiments of the urinary catheter assembly of the invention.</li></ul>

0015In the embodiment shown in <figref idref="f0002">figs. 1 and 2</figref> the urinary catheter assembly of the invention is intended for intermittent catherisation of the bladder of a user and comprises a urinary catheter 1 having a catheter tube 2 with cross-sectional and longitudinal dimensions suitable for introduction of the catheter through the urethra.

0016The catheter tube 2 extends from a distal inlet end 3, in which urine inlet openings 4 are provided, towards a proximal end, at which the catheter tube is connected with an outlet member 5 designed for connection of the catheter with a hose member (not shown) for transport of urine withdrawn from the bladder to a urine collection bag (not shown).

0017On a substantial part of its length from the distal end the catheter tube is, in the illustrated embodiment, coated on its external surface with a hydrophilic surface coating 6 of a kind known per se, which by preparation with a liquid swelling medium prior to use of the catheter provides an extreme low friction character of the catheter surface to enable the catheter to slide very easily through the urethra without exposing the urethral walls to any risk of damage. A hydrophilic surface layer may, however, be provided by other means and may include a catheter tube of which the active part to be located in the urethra is made entirely of a hydrophilic material.

0018Easy withdrawal of the prepared catheter 1 from the package 51 the welding joint may, as illustrated in <figref idref="f0001">figure 7</figref>, comprise a part 10a adjacent the distal end of the catheter tube providing a peel-off joint permitting easy separation of plastic film sheets 8 and 9. Thereby, the package 51 itself will serve as an applicator to be gripped by the user to permit introduction of the catheter tube without contamination.

0019The present compartment for the swelling liquid is separated from the catheter cavity in such a way that the liquid flow communication there between is not established, until preparation of the catheter is performed prior to the intended use. Thereby, only the swelling medium compartment itself needs to have walls of a gas-impermeable material preventing leakage of the swelling medium by diffusion, whereas the wall parts of the package surrounding the catheter may be made of a relatively cheaper liquid tight material.

0020<figref idref="f0002">Figure 1</figref> shows schematically a first embodiment of the catheter assembly of the invention, in which the compartment for the swelling liquid is formed by a pouch-like container 25 arranged around the proximal part 26 of the catheter tube 2 outside the hydrophilic coating 6. The catheter tube passes through the container 25 via sealed openings 27 and 28. The catheter 1 and the pouch-like container 25 are arranged together in the package 29 which may be made from two sets of plastic film material welded together. Preferably, such a package would be designed for peel-off separation of the two sheets from the proximal end 30 to permit withdrawal of the catheter 1 by gripping the catheter outlet or connector member 5. During the withdrawal movement the catheter tube 2 will be drawn through the pouch-like container 25, whereby the swelling liquid will be applied directly to the hydrophilic coating 6.

0021In the container 25 the swelling liquid may be confined in a spongy material.

0022Whereas the container 25 is shown in <figref idref="f0002">figure 1</figref> to be loosely arranged in the package 29, such a container 31 for swelling liquid may also as shown in <figref idref="f0002">figure 2</figref> be secured to one part 32 of a generally tubular package having a second part 33 connected with the part 31 and the container 30 by a welding providing a tear-off facility to allow easy separation of the second part 33 from the package for withdrawal of the catheter 1.

0023In <figref idref="f0003">figure 3</figref> an embodiment is shown with a package 34 for the catheter assembly. The compartment for the swelling liquid is formed by a compressible ampoule 35 arranged in the widened end section 36 of package 34.

0024The ampoule 35 has an outlet part 37 communicating with the opening of the catheter outlet or connector member 5 and being closed by relatively faintly adhering joint 38 which by application of a pressure to the ampoule 35 without opening the package 34 will be opened to allow the swelling liquid to flow through the catheter tube 2 and the distal inlet openings 4 thereof towards the cavity 39 narrowly surrounding the part of the catheter tube 2 provided with the hydrophilic coating 6.

0025In <figref idref="f0003">figure 4</figref> an embodiment is shown in which the swelling liquid is likewise accommodated in a compressible ampoule 40 which is arranged, however, in a separate container part 41 of a two-part container 42 the other part 43 of which defines the cavity for accommodation of the catheter 1 and is in direct liquid flow communication with the outlet part 44 of the ampoule 40. The function of the ampoule 40 in connection with preparation of the hydrophilic catheter coating 6 is generally the same as for the embodiment in <figref idref="f0003">figure 3</figref>, but as a result of the location of the ampoule outlet part 44 in the narrow flow passage 45 between container parts 41 and 43 the swelling liquid will be transferred directly through the cavity to the hydrophilic coating 6 on the external side of the catheter tube 2.

0026In <figref idref="f0002">figure 5</figref> another design of a package in the form of a two part container 46 is shown, wherein the compartment 47 for the swelling liquid is separated from the container part 48 forming the catheter cavity by means of a common closure for the two container parts 47, 48 formed by a sheet member 49 of gas-impermeable film material. The sheet member 49 is connected with a transition part 50 of the package between container parts 47, 48 by a relatively faintly adhering peel-off joint, whereas along all other edge parts of the open container parts 47, 48 there is a relatively strong adhering joint with the common closure sheet 49. By separating the sheet member 49 from container parts 47, 48 the peel-off joint at the transition part 50 may be opened, while maintaining the joint at all other edge parts the compartment formed by container part 47 may be brought into liquid flow communication with the container part 48 accommodating the catheter 1.

0027In <figref idref="f0004">figure 6</figref> a further development of the embodiment shown in <figref idref="f0003">figure 3</figref> is illustrated in which the package 51 is formed integrally with a urine collecting bag 52. For disabled users like paraplegics or tetraplegics who as described in the foregoing may have severe difficulties in entering available toilet rooms such an integration of the urine collecting bag with the catheter package is a significant practical advantage making the use of the catheter totally independant of the availability of a toilet room. The catheter 1 is located in a relatively narrow tapering part 53 joining the collection bag 52 and the compartment for the swelling liquid is formed by a compressible ampoule 54 arranged in flow communication with the catheter outlet or connector member 5. In this case, the catheter 1 will in use not be completely removed from package 51. Instead the distal end of the tapering part 53 may be opened by peel-off separation of two plastic film sheets from which the package 51 is composed.

0028Due to the desirability of limiting the amount of swelling liquid to be contained in the swelling liquid compartment in those embodiments where the swelling liquid is transferred directly through the cavity narrowly surrounding the catheter tube 2 to the hydrophilic coating 6, i.e. without having to flow internally through the catheter tube 2 and through the catheter inlet openings 4, the catheter may be provided with means preventing the swelling liquid from getting into contact with internal or external surface parts of the catheter 1 not provided with the hydrophilic coating 6, during the period needed for preparation of the hydrophilic coating to activate its low friction character. Such means may in a simple manner comprise the application of a film layer 55 of a material soluble by the actual swelling medium to said internal or external surface parts.

0029As shown in <figref idref="f0003">figure 8</figref> this may be done in the most simple way by application of such film layers 55 over the catheter inlet openings 4. Thereby, substantially the entire quantity of swelling medium will be effectively used for the preparation of the hydrophilic surface coating.

0030In <figref idref="f0005">figure 9</figref> a modification of the embodiment shown in <figref idref="f0004">figure 6</figref> is shown, in which a compressible ampoule 54' is loosely arranged in the urine bag part 52' of the catheter package 51'. At one end, the ampoule 54' is closed by a breakable closure device 55, which can be broken off by manipulation through the walls of the bag 52'.

0031In <figref idref="f0006">figures 10 and 11</figref>, an embodiment is shown, in which the compartment for the liquid swelling medium is formed as a rupturable pouch 56 and is arranged in the cavity 57 for the catheter 58 in liquid flow communication with an outlet member 59 connected with the catheter 58 at the proximal end thereof. An outlet part 61 of the ampoule is provided at the end of the pouch facing the catheter outlet member 59. The outlet part 61 is closed by a rupturable closure in the form of a welding 62 providing a relatively faint joint, which will be ruptured by applying pressureon the pouch 56 by squeezing without opening the catheter package. This embodiment is very easy to operate by a user having poor dexterity.

0032In the embodiments to be described in the following the compartment for the swelling medium is formed by a relatively rigid container arranged within the catheter package in extension of an outlet member provided at the proximal catheter end.

0033In the embodiment shown in <figref idref="f0007">figures 12 and 13</figref> this container is formed as a relatively flat box 63 which at an end facing the catheter outlet member 64 is closed by a closure in the form of a rupturable membrane 65, connected with an operating device permitting rupturing of the membrane without opening the catheter package.

0034In the embodiment shown this operating device comprises a rod-like member 66 connected with the membrane 65 and extending throughout the length of the box-shaped container 64 and through an end wall 67 of the catheter package to a gripping member 68, which can be operated by the user to rupture the membrane 65, whereby the swelling medium content in the container 63 will flow through the catheter 69 in the manner described in the foregoing.

0035As illustrated in <figref idref="f0007">figure 13</figref>, a particular easy operation may be obtained, if the gripping member 68 is formed as a ring, which will allow the catheter package as a whole to be hung on a hook 70 or similar device, which is normally available in a toilet or bathroom. Operation of the package to effect treatment of the hydrophilic surface part of the catheter 69 may then be effected by pulling the entire package hung on such a hook.

0036In the modification illustrated in <figref idref="f0008">figures 14 and 15</figref>, a compartment in the form of a flat box-like container 71 somewhat similar to the container 63 shown in <figref idref="f0007">figures 13</figref> and <figref idref="f0008">14</figref>, is formed with an open end 72 facing the catheter outlet member 73. A sealing closure between the compartment accomodating the liquid swelling medium and the catheter cavity 74 of the package is obtained by means of an external clamp 75 squeezing the walls of the catheter package 76 together. Thereby, the treatment of the hydrophilic surface part of the catheter 77 can simply be effected by removing the clamp 75.

0037In the embodiment shown in <figref idref="f0009">figures 16 and 17</figref>, a rigid container compartment 78 for the liquid swelling medium has a generally conical shape and is formed integrally with the catheter outlet member 79 in extension thereof. Between the outlet member 79 and the container 78 a fracture region 80 is provided allowing the container 78 to be easily broken off from the catheter outlet member 79, whereby a liquid-tight closure in the form of a membrane 80a closing the end of the container 78 facing the outlet member 79 will automatically be ruptured to allow the content of liqid swelling medium in the container 78 to flow through the catheter 81 to effect treatment of the hydrophilic surface part thereof.

0038In <figref idref="f0010">figures 18 and 19</figref>, an embodiment is illustrated in which an ampoule 82 accomodating the liquid swelling medium is arranged within the catheter package in extension of the catheter outlet member 83. The ampoule 82 is connected with an operation member 84 through a connecting assembly 85 comprising a plug-like closure member 87 formed integrally with the operation member 84 and pivotally connected with a collar member 86 secured to the ampoule 82, whereby the ampoule 82 can be pivoted with respect to the operation member 84, by gripping the latter together with the catheter outlet member without opening the package, to assume the position shown in dashed lines, whereby the closure 87 will be removed from the ampoule to allow the liqud swelling medium to flow out and effect treatment of the hydrophilic surface part of the catheter 88.

0039In <figref idref="f0010">figure 20</figref>, a modification of the embodiment in <figref idref="f0010">figures 18 and 19</figref> is shown, in which an ampoule 89 for the liquid swelling medium is closed by a rupturable membrane 90 and is connected with an operation member 92, which in the package is located opposite the end of the catheter outlet member 91 and is formed, on its inner side facing the membrane 90, with a rupturing projection 93. The operation member 92 is arranged to be displaceable on a neck part of the ampoule 89 and is normally held thereon in an inactivated position, in which the rupturing projection 93 is removed from the membrane 90, by means of projecting pins 94 engaging a recess 94a formed in the operation member 92. The membrane 90 can be ruptured by the rupturing projection 93 without opening the catheter package by operating the catheter outlet member 91 to push the operation member 92 with respect to the ampule neck part 94.

0040In a further modification illustrated in <figref idref="f0010">figure 21</figref>, an ampoule 95 closed by a rupturable membrane 96 is connected with the catheter outlet member 97 by an operation member comprising two pitally interconnected parts 98 and 99 connected with outlet member 97 and ampoule 95, respectively. Operation member part 98 is formed with a rupturing projection 100 for membrane 96. Activation of the ampoule 95 by rupturing the membrane 96 may be effected without opening the catheter package by pivoting the ampoule 95 with respect to the catheter outlet member 97 from the supply position shown in solid lines, in which the ampoule 95 extends parallel with respect to the catheter, to the activation position shown in dashed lines.

0041In the embodiment shown in <figref idref="f0011">figures 22 and 23</figref>, the catheter package 101 providing the cavity for the catheter 102 is closed at the end opposite the catheter outlet member 103 by a rigid end wall 104 and the compartment for the liquid swelling medium is formed by an external rigid container 105 arranged outside the package itself against the end wall 104. As illustrated, the container 105 is arranged to be turnable through approximately 90° with respect to the end wall 104 to bring liquid outlet and inlet openings provided in an end wall 106 of the container 105 facing the rigid end wall 104 and in the latter end wall, respectively, into liquid flow alignment, whereby the content of liquid swelling medium in the ampoule 105 will be transferred to the catheter package to effect treatment of the hydrophilic surface part of he catheter 102.

0042Whereas different embodiments of ready to use urinary catheter assemblies according to the invention have been described in the following the invention is not limited to the specific characteristics of these embodiments, but will include numerous modifications without departing from the scope of the patent claims.